Mice, men, and monsters: Opposition to chimera research and the scope of federal regulation

California Law Review

Volumn 96, Issue 3, 2008, Pages 765-800

  Sherringham, Tia ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

EID: 47749146925     PISSN: 00081221     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Note

References (252)

1. See id.
2. President George W. Bush, State of the Union Address (Jan. 31, 2006).
3. See President George W. Bush, supra note 2.
4. Stem cells are cells that have the ability to divide indefinitely and can turn into specialized cells, such as those in the heart, brain or bone. The predominant way to produce human stem cells is to take them from a recently fertilized human embryo, destroying the embryo in the process. See National Institutes of Health, Glossary [Stem Cell Information], http://stemcells.nih.gov/StemCells/Templates/StemCellContentPage.aspx?NRMODE= Published-&NRNODEGUID=%7b3C35BAB6-0FE6-4C4E-95F2- 2CB61B58D96D%7d&NRORIGINALURL=%2finfo%2fglossary%2easp&NRCACHEHINT= NoModifyGuest#stemcells (last visited Jan. 22, 2008);
5. see also Gina Kolata, Scientists Bypass Need For Embryo To Get Stem Cells, N.Y. TIMES, Nov. 21, 2007, at A1.
6. See Jamie Shreeve, The Other Stem-Cell Debate, N.Y. TIMES, Apr. 15, 2005, at 2, available at http://www.nytimes.com/2005/04/10/ magazine/10CHIMERA.html?ex=1270872000&en=c4be0212ead15076&ei=5088.
7. Id. at 2.
8. HUMAN EMBRYONIC STEM CELL RESEARCH ADVISORY COMMITTEE, GUIDELINES FOR HUMAN EMBRYONIC STEM CELL RESEARCH 50 (2005), available at http://www.nap.edu/catalog/11278.html.
9. See Human Chimera Prohibition Act, S. 659, 109th Cong. (2005).
10. See id.
11. See Shreeve, supra note 5, at 1;
12. see also ROBERT GRAVES, THE GREEK MYTHS (rev. ed. 1960).
13. D. Scott Bennett, Comment, Chimera and the Continuum of Humanity: Erasing the Line of Constitutional Personhood, 55 EMORY L.J. 347, 347-48 (2006). It is important to note that chimeras are not hybrids, which are created as a result of sexual reproduction across species and contain recombined genes throughout their bodies.
14. See Francois Baylis & Jason Scott Robert, Part-Human Chimeras: Worrying the Facts, Probing the Ethics, 7 AM. J. BIOETHICS 41 (2007).
15. See Phillip Karpowicz, Cynthia B. Cohen & Derek van der Kooy, It Is Ethical To Transplant Human Stem Cells Into Nonhuman Embryos, 10 NATURE MED. 331 (Apr. 2004).
16. See id. at 110.
17. See id. A zygote is a cell formed by the union of an egg cell and sperm cell.
18. See id.
19. Jason Scott Robert & Francoise Baylis, Crossing Species Boundaries, 3 AM. J. BIOETHICS 1, 2 (Summer 2003).
20. See Karpowicz, supra note 12, at 110.
21. There are three sources of hES cells. The first is to pluck them from an early stage human embryo, destroying the embryo in the process. The second is to use adult stem cells found in differentiated human tissue. The newest method is to insert a retrovirus into human skin cells which reprograms the cells, causing them to behave like stem cells. The risks involved in the last method are yet to be determined. See National Institutes of Health, supra note 4;
22. see also Kolata, supra note 4, at A1.
23. See Bennett, supra note 11, at 351.
24. See id.
25. See Robert Gifford, Listen Now, Scientists Hope to Create Human-Animal Embryo (National Public Radio broadcast Sept. 5, 2007) available at http://www.npr.org/templates/story/story.php?storyId= 14191423;
26. see also David Batty, Hybrid Embryos Get Go-Ahead, GUARDIAN UNLIMITED, May 17, 2007, http://www.guardian.co. uk/medicine/story/0,,2081755.00.html (for discussion of proposal prior to date of approval).
27. See Shreeve, supra note 5, at 111-12.
28. See Bennett, supra note 11, at 351-52.
29. See id.
30. See id.
31. See id.
32. See id.
33. See Karpowicz, supra note 12, at 334.
34. Id.
35. See Karpowicz, supra note 12.
36. Daniel S. Levine, Working On Chimeras Could Put Scientists in the Doghouse, S.F. BUS. TIMES, May 12, 2006, at 1, available at http://sanfrancisco.bizjournals.com/sanfrancisco/stories/ 2006/05/15/newscolumn5.hrml?page= 1.
37. See Shreeve, supra note 5.
38. See id. at 2.
39. See id.
40. See id.
41. See Bennett, supra note 11.
42. See id.
43. See id.
44. See Shreeve, supra note 5 at 1.
45. See id.
46. See id.
47. See id. at 5.
48. See id.
49. Id. at 4-5 (quoting Greenley's statement to National Academy of Sciences panel).
50. See William Saletan, Making Manimals, WASH. POST, June 24, 2007, at B02, available at http://www.washingtonpost. com/wp-dyn/content/article/2007/06/22/AR2007062201643.html (stating that Stanford ethicists are at a point where they have detailed a proposal for a neural mouse).
51. See Bennett, supra note 11, at 353.
52. Id.
53. See Ali Khademhosseini, Robert Langer, Jeffrey Borenstein & Joseph P. Vacanti, Microscale Technologies for Tissue Engineering and Biology, 103 PROCEEDINGS NAT'L ACADEMY SCI. U.S.A. 2480 (Feb. 21, 2006), available at http://www.pnas.org/cgi/content/full/103/8/2480.
54. See id.
55. See id.
56. See Sylvia Pagan Westphal, 'Humanized' Organs Can Be Grown in Animals, NEW SCIENTIST, Dec. 17, 2003, available at http://www.newscientist.com/article.ns?id=dn4492.
57. See id.
58. For ethical reasons, certain experiments-such as grafting human neural cells into humans solely for experimental purposes-are prohibited even if they would lead to human treatments, making research on chimeras more attractive. See Mark Greene et al, Moral Issues of Human-Nonhuman Primate Neural Grafting, 309 SCI. MAG. 385, July 15, 2005, available at http://www.sciencemag.org/cgi/content/full/309/5733/385;
59. see also Bennett, supra note 11, at 353.
60. See Robert Streiffer, At the Edge of Humanity: Human Stem Cells, Chimeras, and Moral Status, 15 KENNEDY INST. ETHICS J. 347, 349 (2005).
61. See id.
62. See The Joint Steering Comm. for Public Policy, S. 1373, The Human Chimera Prohibition Act of 2005: Talking Points, available at http://www.stemcellfunding.org/resources/Facts%20About%20Chimeras.pdf.
63. See Karpowicz, supra note 12, at 331.
64. See Saletan, supra note 45;
65. see Streiffer, supra note 54, at 349.
66. Alysson R. Muotri et al., Development of Functional Human Embryonic Stem Cell-Derived Neuros in Mouse Brain, 102 PROC. NAT'L ACAD. SCI. U.S.A. 2(Dec. 13, 2005), available at http://www.pnas.org/cgi/content/abstract/0509315102v1.
67. See id. at 10.
68. See id. at 2.
69. Ronald Bailey, Shimmering Chimeras: Moving Sheepishly Toward the Biotech Future, REASON, Dec. 24, 2003, http://www.reason.com/news/ show/34931.html;
70. see also Karpowicz, supra note 12.
71. See Nicole Kopiniski, Human-Nonhuman Chimeras: A Regulatory Proposal on the Blurring of Species Lines, 45 B.C. L. REV. 619, 629 (2004).
72. Mark Dowie, Gods and Monsters, MOTHER JONES (2004), available at http://www.motherjones.com/news/feature/2004/01/ 12_401.html.
73. Id. In the United States, the "one-drop" rule is a historical colloquial term suggesting that a person with any known African black ancestry cannot be considered white.
74. See FLOYD JAMES DAVIS, WHO IS BLACK? ONE NATION'S DEFINITION 5 (1991), available at http://www.pbs.org/wgbh/pages/frontline/shows/jefferson/ mixed/onedrop.html.
75. See Dowie, supra note 64.
76. See Bailey, supra note 62.
77. See Streiffer, supra note 54, at 347.
78. See id.
79. See id.
80. See id.
81. See id. at 350.
82. Id.
83. See Shreeve, supra note 5.
84. See Karpowicz, supra note 12, at 108.
85. Robert, supra note 16, at 5.
86. Id. at 7 (citing J. HARRIS, CLONES, GENES, AND IMMORALITY: ETHICS AND THE GENETIC REVOLUTION 177 (1998)).
87. See id.
88. See Shreeve, supra note 5.
89. Leon R. Kass, The Wisdom of Repugnance, in THE ETHICS OF HUMAN CLONING 19 (Leon R. Kass & James Q. Wilson eds., 1998).
90. See Karpowicz, supra note 12, at 110-11.
91. See id.
92. See Julian Sanchez, Discussing Disgust: On the folly of gross-out public policy. An interview with Martha Nussbaum, REASON ONLINE, July 15, 2004, http://www.reason.com/news/show/33316.html.
93. See id.
94. Streiffer, supra note 54, at 351.
95. Yilin Cao et al., Transplantation of Chondrocytes Utilizing a Polymer-Cell Construct to Produce a Tissue-Engineered Cartilage in the Shape of a Human Ear, 100 PLASTIC RECONSTRUCTIVE SURGERY 297, 297-302 (1997).
96. See Streiffer, supra note 54, at 351.
97. See id. at 352 ("[I]t is not remotely plausible to think that the mere visual appearance of the mouse makes such research wrong.").
98. See Shreeve, supra note 5.
99. Gametes are eggs and sperm.
100. Shreeve, supra note 5, at 4.
101. Id. at 3.
102. Id. at 4.
103. Id. at 4.
104. See Streiffer, supra note 54, at 352.
105. See id. at 362.
106. Id. at 353.
107. See id. at 362.
108. See id.
109. See id.
110. See id.
111. See id.
112. See id. at 353.
113. The thalamocortical system constitutes the majority of the mammalian brain.
114. See Karpowicz, supra note 12, at 334.
115. See Streiffer, supra note 54, at 355.
116. Further, when asked about the effects of introducing neural hES cells into an animal early in development, Dr. Fred Gage, specialist of neuroplasticity and neural stem cells at the Salk Institute, has said "we don't know the answer to [this] question because the experiment hasn't been done, that I know of." Id. at 356.
117. See id.
118. See Food Security Act of 1985, Pub. L. No. 99-198 § 1752, 99 Stat. 1645 (1985).
119. Id. at § 1752(c).
120. Animal-rights supporters could also argue that creating human-nonhuman chimeras purely to benefit humans constitutes animal cruelty. However, IACUCs are equipped to monitor the conditions of chimera experimentation to ensure the ethical treatment of chimeras.
121. See Bennett, supra note 11, at 354.
122. See Westphal, supra note 51.
123. See Center for Disease Control and Prevention, Fact Sheet: What You Should Know About Monkeypox, June 12, 2003, available at http://www.cdc.gov/ncidod/monkeypox/factsheet2.htm.
124. See Human Chimera Prohibition Act, supra note 8.
125. See John Rennie, Human-Animal Chimeras: Some Experiments Can Disquietingly Blur the Line Between Species, FIN. TIMES, July 2005, at A8, available at http://search.ft.com/ftArticle?ct= 0&id=050617005535 (explaining the risks of intermingling animal and human tissues).
126. See David Brown, Resurrecting 1918 Flu Virus Took Many Turns, WASH. POST, Oct. 10, 2005, available at http://www.washingtonpost.com/wp-dyn/content/article/2005/10/09/AR2005100900932. html.
127. See Karpowicz, supra note 12, at 110.
128. See id. at 331.
129. See Robert, supra note 16, at 7.
130. Id.
131. See Karpowicz, supra note 12, at 111-12.
132. See id. at 112.
133. See id.
134. See id. at 112-113.
135. See Bennett, supra note 11, at 354.
136. See Robert, supra note 16, at 7.
137. See Bennett, supra note 11, at 354.
138. See Tara Seyfer, The Ethics of Chimeras and Hybrids, 29 ETHICS & MEDICS 8 (2004), available at http://www.lifeissues.net/ writers/sey/sey_02etl-cschimeras.html;
139. see also Genesis 1:26-28 (claiming man's stewardship over animals), available at http://www.biblegateway.com/passage/?search= Genesis%201%20:26;&version=31.
140. Yitzchok Breitowitz, What's So Bad About Human Cloning?, 12 KENNEDY INST. ETHICS COUNS. 325, 327 (2002).
141. Paul Elias, Mice Created With Human Brain Cells, ASSOCIATED PRESS, Dec. 12, 2005, at 2, available at http://www.breitbart.com/article.php?id=D8EFlM2O0&show_article=1.
142. See Shreeve, supra note 5, at 2 ("We have to be sure we are not creating beings with consciousness," Francoise Baylis, a bioethicist at Dalhousie University in Halifax, Nova Scotia.).
143. See supra Section II.B.i Concern for Animal Welfare.
144. See Streiffer, supra note 54, at 354 (suggesting that the "moral status principles" is the strongest rationale in opposition of chimera research).
145. See Genesis 1:26-28, available at http://www.biblegateway. com/passage/?search= Genesis%201%20:26;&version=31.
146. See Christine M. Korsgaard, Tanner Lecture on Human Values at the University of Michigan: Fellow Creatures: Kantian Ethics and Our Duties to Animals 9 (Feb. 6, 2004), available at http://www.people.fas.harvard.edu/ ~korsgaar/CMK.FellowCreatures.pdf.
147. See Streiffer, supra note 54, at 353-54.
148. See id.
149. See Robert, supra note 16, at 9.
150. See generally Greene, supra note 53.
151. See id.
152. See Robert, supra note 16, at 2 (discussing the view that "species identity is fixed and that species boundaries are inappropriate objects of human transgression.").
153. See Bennett, supra note 11, at 354.
154. See Robert, supra note 16, at 5.
155. See Karpowicz, supra note 12, at 332.
156. See Robert, supra note 16, at 2.
157. Chemical compounds which are the structural units of DNA.
158. See id. at 4.
159. See Shreeve, supra note 5.
160. See Karpowicz, supra note 12, at 333;
161. see also Robert, supra note 16, at 6.
162. See Robert, supra note 16, at 2.
163. See id. (explaining that "the safety and efficacy of engrafting fetal pig cells has been studied in people with Parkinson's disease and Huntington's disease without moral objection."). A xenograft is a transplant of cells, tissues or organs taken from a donor of one species and implanted into a recipient of another species.
164. Karpowicz, supra note 12, at 333.
165. Shreeve, supra note 5, at 110-11.
166. See Karpowicz, supra note 12, at 333.
167. See id.
168. See Shreeve, supra note 5, at 2-3 (explaining that "the Senator may not trigger a yuck.").
169. See Sam Brownback, U.S. Sen., Keynote Address at the Harvard Law School Society for Law, Life & Religion 2005 Symposium: Law & Ethics in a Brave New World: What Should Government Do About Cloning and Stem Cell Research? (Apr. 15, 2005).
170. The moral code Brownback refers to stems from the Hippocratic Oath: "As to diseases, make a habit of two things-to help, or at least do no harm." Id. at 1.
171. See id.
172. Id. at 2.
173. The only exception to Brownback's 100% rating from the National Right to Life Committee occurred when he supported the McCain-Feingold campaign-finance bill (which the NRLC deemed hostile not because it favored abortion, but because it restricted the activities of political advocacy groups). Brownback is also the author of the Unborn Child Pain Awareness Act. See John Miller, Saint Sam: Senator Brownback of Kansas is one of the Country's Leading Virtuecrats, NAT'L REV., May 8, 2006, available at http://www.findarticles.eom/p/articles/mi_m1282/is_8_58/ai_n16359554/pg_3.
174. Brownback, supra note 158, at 2.
175. Id. at 5.
176. Id. at 6.
177. See id.
178. See id.
179. Id.
180. Id.
181. Human Chimera Prohibition Act, supra note 8, at § 2.
182. See Brownback, supra note 15 8, at 5.
183. Id.
184. Id. at 7.
185. See Henry T. Greely, Human/Nonhuman Chimeras: Ethical, Legal and Policy Considerations, EARTH & LIFE STUD. NAT'L ACAD., http://dels.nas.edu/bls/stemcells/docs/Greely2. pdf (last visited Feb. 25, 2007).
186. See id.
187. See Human Chimera Prohibition Act, supra note 8, at § 301(1)(C)-(D).
188. See id. at § 301 (1)(E)-(F).
189. A somatic cell is any cell in the body other than an egg or sperm cell.
190. See Robert, supra note 16, at 4.
191. Id.
192. See The Joint Steering Comm., supra note 56.
193. Human Chimera Prohibition Act, supra note 8, at § 301(1)(1).
194. See The Joint Steering Comm., supra note 56.
195. See Human Chimera Prohibition Act, supra note 8, at § 2(2) (citing "serious ethical objections" as a premise for the bill).
196. See Lawrence v. Texas, 539 U.S. 558 (2003).
197. See id. at 578.
198. Id. at 571 (quoting Planned Parenthood of Southeastern Pa. v. Casey, 505 U.S. 833, 850 (1992)).
199. See id. at 574.
200. Id. (quoting Casey, 505 U.S. at 851).
201. Id. at 582 (O'Connor, J., concurring).
202. See Lawrence v. Texas, 539 U.S. 558, 578 (2003);
203. see also id. at 585 (O'Connor, J., concurring).
204. See Levine, supra note 31 (citing Hank Greely for the proposition that "[legislators] don't know the science, and the science changes really rapidly. What they should focus on is the process.").
205. See J. Scott Orr, Merging Animal, Human Cells- Where's the Line?, S.F. CHRON., Mar. 12, 2006, available at http://www.sfgate.com/cgi-bin/article.cgi?file=/chronicle/archive/2006/03/12/ LNG4THKUAO1.DTL.
206. In 2007, the NAS published amendments to the 2005 Guidelines. The amendments noted the need for further direction on chimera research but postponed making additional recommendations. See HUMAN EMBRYONIC STEM CELL RESEARCH ADVISORY COMMITTEE, 2007 AMENDMENTS TO THE NATIONAL ACADEMIES' GUIDELINES FOR HUMAN EMBRYONIC STEM CELL RESEARCH 3 (2007), available at http://www.nap.edu/catalog.php?record_id=11871.
207. See HUMAN EMBRYONIC STEM CELL RESEARCH ADVISORY COMMITTEE, supra note 7, at 7.
208. See id. at 7 § (b)(ii).
209. A blastocyst is a pre-implantation embryo consisting of 50-250 cells depending on its age.
210. See HUMAN EMBRYONIC STEM CELL RESEARCH ADVISORY COMMITTEE, supra note 7. at 8.
211. See id.
212. PRESIDENT'S COUNCIL FOR BIOETHICS, CHAPTER IO: RECOMMENDATIONS, REPRODUCTION AND RESPONSIBILITY: THE REGULATION OF NEW BIOTECHNOLOGIES 8-9 (Mar. 2004), available at http://bioethics.gov/reports/reproductionandresponsibility/chapter10.html.
213. Id.
214. See id. at 8-9.
215. A blastomere is a type of cell produced by division of the egg after fertilization and prior to the cell differentiation of the inner cell mass and the outer-layer of cells (trophectoderm).
216. See PRESIDENT'S COUNCIL FOR BIOETHICS, supra note 200, at 9.
217. See id.
218. Id. at 8.
219. See id. at 9.
220. See Lawrence, 539 U.S. at 582.
221. See The Joint Steering Comm., supra note 56.
222. See CALIFORNIA INSTITUTE FOR REGENERATIVE MEDICINE, FINAL COMPILED PROPOSED CIRM MES REGULATIONS: PREPARED FOR REVIEW BY THE INDEPENDENT CITIZEN'S OVERSIGHT COMMITTEE OF THE CALIFORNIA INSTITUTE FOR REGENERATIVE MEDICINE § 100020: Definitions (Aug. 31, 2007), available at http://www.cirm.ca.gov/reg/pdf/Regs100010. pdf.
223. See id. at § 10030: Activities Not Eligible for CIRM Funding (c)-(e).
224. A pluripotent cell is a single cell with the capability of developing into cells of all germ layers (endoderm, ectoderm, and mesoderm).
225. See Streiffer, supra note 54, at 365.
226. See id. at 366.
227. See Karpowicz, supra note 12, at 334.
228. Human Chimera Prohibition Act, supra note 8, at § 301(1)(1).
229. See Greene, supra note 5 3.
230. See World Wildlife Fund, http://www.worldwildlife.org/apes/ chimpanzee.cfm;
231. see also John Pickrell, Chimps Belong on Human Branch of Family Tree Study Says, NATIONAL GEOGRAPHIC, May 20, 2003, available at http://news.nationalgeographic.com/news/2003/05/
232. 0520_030520_chimpanzees.html (describing how closely related chimps are to humans).
233. See Catherine Arnst, The Dynamic Duo of Tissue Engineering, BUS. WK., July 17, 1998, available at http://www.businessweek.com/1998/30/b3588008.htm.
234. See Karl S. Kruszelnicki, Mouse with Human Ear: Great Moments in Science, ABC, 2006, http://www.abc.net.au/science/k2/moments/s1644154.htm (describing the outrage of the Turning Point Project and the full page ad they printed in protest).
235. See HUMAN EMBRYONIC STEM CELL RESEARCH ADVISORY COMMITTEE, supra note 7, at 6 ("Other types of studies should not be permitted at this time (such as ... breeding of any interspecies chimera).");
236. see also PRESIDENT'S COUNCIL FOR BIOETHICS, supra note 200, at 9 (recommending that Congress "prohibit the production of a hybrid human-animal embryo.");
237. see also Human Chimera Prohibition Act, supra note 8, at § 301 (D)-(E).
238. See, e.g., HUMAN EMBRYONIC STEM CELL RESEARCH ADVISORY COMMITTEE, supra note 7, at 6 ("for example the creation of a chimera might involve both an Institutional Review Board (IRB), if cells are to be obtained from human donors for research, and an Institutional Animal Care and Use Committee (IACUC), if animals are to be used in the research.").
239. See 45 C.F.R. § 46.109 (2005), available at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.109 (explaining that an IRB must review human subject research);
240. see also OFFICE FOR HUMAN RESEARCH PROTECTIONS DEPARTMENT OF HEALTH AND HUMAN SERVICES, GUIDANCE FOR INVESTIGATORS AND INSTITUTIONAL REVIEW BOARDS REGARDING RESEARCH INVOLVING HUMAN EMBRYONIC STÉM CELLS, GERM CELLS AND STEM CELL-DERIVED TEST ARTICLES (2002) (stating that "[a]11 clinical research involving ... biological products ... is also subject to FDA regulations.").
241. See 45 C.F.R. § 46.122 (stating that "[fjederal funds administered by a department or agency may not be expended for research involving human subjects unless the requirements of [IRB review] have been satisfied.").
242. See Human EMBRYONIC STEM CELL RESEARCH ADVISORY COMMITTEE, supra note 7, at 5 (suggesting that "the [ESCRO] committee should include representatives of the public and persons with expertise in developmental biology, stem cell research, molecular biology, assisted reproduction, and ethical and legal issues in hES cell research.").
243. See INTERNATIONAL SOCIETY FOR STEM CELL RESEARCH, GUIDELINES FOR THE CONDUCT OF HUMAN EMBRYONIC STEM CELL RESEARCH (RECOMMENDATIONS FOR OVERSIGHT), 6-7 (Version 1 2006).
244. See id. at 8.
245. See, e.g., Greene, supra note 50, at 386 (suggesting six factors that research oversight committees should consider).
246. See INTERNATIONAL SOCIETY FOR STEM CELL RESEARCH, supra note 226. at 5, § 8.3(a)-(b).
247. See id. at 5, § 8.3 (c).
248. See Greene, supra note 53, at 386.
249. See id. at 3 (claiming that the "potential for engrafted cells to have significant functional influence will be markedly greater for engraftment at very early stages of development.")
250. See Shreeve, supra note 5, at 6.
251. See id.
252. See id.